Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Phase Ⅱ,Open Label Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01305980
• Other study ID #: SB injection-C002
• Status: Recruiting
• Phase: Phase 2
• First received: February 25, 2011
• Last updated: March 3, 2011
• Start date: December 2010
• Est. completion date: March 2012

Study information

• Verified date: March 2011
• Source: SBPharmaceutical IND, Co., LTD
• Contact: Yong-oon Shin, Prof.
• Phone: 032-890-2548
• Email: ywshin[@]inha.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine efficacy of SB injection in Colorectal Cancer.

Description:

All eligible patients will receive SB injection therapy for 6 cycles (14~21 days for each cycle). Efficacy will be evaluated every 3 cycles.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age of 18years or over

• Patients who had failed more than 1 cycle of standard therapy with advanced or metastatic stage and with measurable lesions

• Life expectancy >/= 5 months

• Not available to any of resectable surgery or radiotherapy

• Patients with adequate organ(e.g. heart, kidney, liver)and bone marrow function, as defined by

1. Absolute neutrophil count >/= 1.0 x 10^9/L, Platelet count >/= 75 x 10^9/L

2. Total bilirubin < 2.0 mg/dL

3. Aspartate Aminotransferase and/or Aspartate Aminotransferase < 5 x Upper Limit Normal

4. creatinine < 2 x Upper Limit Normal

• ECOG status 0 to 2

• Female volunteers admitted to the study must be using a reliable means of contraception and must have a negative blood or urine pregnancy test at least 7days ago

• Patients or their legal representatives who have signed the informed consent form.

Exclusion Criteria:

• Have inflammatory bowel diseases

• Have severe diarrhea or ileus

• Previous total colectomy

• Have ileostomy

• Known brain or spinal cord metastases

• Patients who have received chemotherapy within the previous 4 weeks

• Patients who have received radiotherapy related tp colorectal cancer within 4weeks

• Patients who have participated in other clinical study within the previous 4weeks

• Pregnancy or lactation period

• Human Immunodeficiency Virus antibody (+)

• Have active infection or serious concomitant systemic disorder incompatible with the study

• Clinically hypertension or diabetes mellitus not well controlled with medication

• Clinically significant cardiac disease(congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction

• Presence or history of malignancy other than colorectal cancer within 5years

• Have severe Neurologic or psychological disorder

• Patients who have history of allergy with this investigational drug(SB injection)

• Obvious cognitive or physical impairment that would prevent participation

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• SB injection
Infusion SBinjection of 21.87ml/m^2, IV route, 24times for 4 months

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Incheon	Jung-gu

Sponsors (1)

Lead Sponsor	Collaborator
SBPharmaceutical IND, Co., LTD

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating Tumor Response Rate		4 months	No
Secondary	Pain Scores on the Visual Analog Scale		4 months	No
Secondary	evaluate patient's performance by measuring Eastern Cooperative Oncology Group scale		4 months	No
Secondary	Determine duration of response rate by measuring time to progression		4 months	No

External Links

•   SBP